GOG PHASE I WORKING GROUP
MEMBERSHIP APPLICATION
The GOG is considering the expansion of the Phase I Working Group of institutions to be appointed by the Group Chair. This group of institutions is responsible for performing phase I trials of new agents in gynecologic cancer and functions as a subcommittee of the Developmental Therapeutics Committee. Affiliate institutions may not participate except by special permission.
All full member institutions are eligible for consideration as members of the Phase I Working Group. To be considered, the institution must submit an application to be reviewed by the Chair and Co-Chair of the Developmental Therapeutics Committee. Applications should be submitted to:
GOG Phase I Working Group
c/o Gynecologic Oncology Group
Administrative Office
Four Penn Center, Suite 1020
1600 John F. Kennedy Boulevard
Philadelphia, PA 19103
The proper format for the application is as follows:
Section I - Identification: This section should identify the institution, the principal investigator, and the individual who will be primarily responsible for the phase I activities at the institution. NOTE: Affiliate institutions may not participate except by special permission.
Section II - Personnel: This section should name each individual who will be a participant in the phase I activities at the institution. In this regard, a high premium will be placed on multidisciplinary participation since a variety of different agents may be under study by the group and may include chemotherapy, biologic response modifiers, radiosensitizers, and combination regimens. Capabilities to conduct such activities as pharmacologic and pharmacokinetic studies are desirable but not essential. Biographical sketches of each individual should be included in the format used for NIH grants.
Section III - Prior Experience: This section should detail the prior experience of the individual in charge of the phase I effort as well as the experience of the team. It should include a listing of all phase I publications generated by the team members.
Document your experience with or future plans for sample procurement. For example, is dedicated staff available to obtain timed blood specimens, process the specimens, and prepare for shipping?
Detail strengths and expertise that your institution would bring to the Phase I group. If you have specific expertise in a given area, such as pharmacokinetics, correlative studies, vaccines, intraperitoneal therapies, or chemoradiotherapy, please describe. In particular, describe any ideas for translational studies that could be evaluated in the cooperative group setting.
Section IV - Methods: This section should discuss briefly (4 pages or less) methods to be used by the institution in the conduct of phase I activities.
Section V - Commitment: This section should be a brief statement of commitment to the Phase I Working Group as a priority for the institution's clinical research effort followed by the signature of the GOG Principal Investigator (and Co-Principal Investigator where applicable) and the individual in charge of the phase I activities for the institution.
Section VI – Membership: Maintenance of Phase I member status will be contingent upon adequate accrual. A reasonable goal would be ten (10) patients per year, assuming activation of five (5) studies at your institution. Please provide some documentation of your ability to accrue to this type of study, e.g., accrual to second line GOG or pharmaceutical studies, or salvage in-house protocols. Alternatively, documentation of patient population such as tumor registry data, with a statement that there are no competing trials and an explanation of how Phase I accrual will be maintained.
Completed applications are due forty-five (45) days prior to the next regularly scheduled Semi-Annual Meeting, and will be acted upon during that meeting.
Completed applications should be submitted to the GOG Administrative Office.